Modality
Vaccine
MOA
BCL-2i
Target
CD123
Pathway
Neuroinflam
NMOSDPAH
Development Pipeline
Preclinical
~Mar 2010
→ ~Jun 2011
Phase 1
~Sep 2011
→ ~Dec 2012
Phase 2
~Mar 2013
→ ~Jun 2014
Phase 3
~Sep 2014
→ ~Dec 2015
NDA/BLA
~Mar 2016
→ ~Jun 2017
Approved
Sep 2017
→ Aug 2027
ApprovedCurrent
NCT08248176
2,995 pts·NMOSD
2017-09→2027-08·Completed
NCT08582893
1,011 pts·PAH
2021-09→TBD·Active
NCT03519947
1,879 pts·NMOSD
2021-08→2025-06·Recruiting
+1 more trial
8,882 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2025-06-1110mo agoPh3 Readout· NMOSD
2027-08-151.4y awayPh3 Readout· NMOSD
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
Approved
Complet…
Approved
Recruit…
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2025-06-11 · 10mo ago
NMOSD
Ph3 Readout
2027-08-15 · 1.4y away
NMOSD
RecruitingActiveCompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08248176 | Approved | NMOSD | Completed | 2995 | OS |
| NCT08582893 | Approved | PAH | Active | 1011 | DOR |
| NCT03519947 | Approved | NMOSD | Recruiting | 1879 | HbA1c |
| NCT08324852 | Approved | PAH | Terminated | 2997 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| REG-7737 | Regeneron | Preclinical | CD123 | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D | |
| HAL-996 | Halozyme | Phase 1/2 | BCL-2 | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 |